Regulatory Strategy

HOME  /  SOLUTIONS  /  REGULATORY STRATEGY REGULATORY STRATEGY We offer a distinct and tailored approach HOW CAN WE HELP? SCROLL Overview Allucent offers biopharma companies support in advancing through the complex global regulatory requirements through its regulatory strategy services. Allucent's team, which includes many former regulators, brings deep experience with regulatory pathways to help guide product planning. In addition to supporting the regulatory submission and approval process, Allucent also supports ongoing regulatory compliance and continued product development post-approval. REGULATORY & DRUG DEVELOPMENT CONSULTING Are you facing challenges in navigating the regulatory complexities of drug development? Are you looking for a partner who can seamlessly integrate with your team and deliver innovative solutions that drive your key milestones to success? We understand the challenges faced by our clients and offer a distinct and tailored approach to regulatory and drug development consulting that sets us apart. Regulatory Submissions and Experience With 12 former regulators From 6 regulatory agencies And 825+ annual regulatory submissions Plus, a track record of 105+ successful marketing applications REGULATORY & DRUG DEVELOPMENT CONSULTING From early drug development through submission & marketing approval to post registration, we bring our passion for innovation, unparalleled expertise and a partnership approach. We are Allucent. Our focus is on you. “We benefited greatly from their deep experience and their professional, yet comfortable working relationship. The most impressive part about working with Allucent is that they can be trusted to deliver what they promise.” SENIOR VICE PRESIDENT OF CLINICAL DEVELOPMENT AND MEDICAL AFFAIRS “The Universal Biosensors team worked hand-in-hand with Allucent’s subject matter experts in regulatory strategy and statistics to support the recent 510(k) approval and CLIA Waiver of the Xprecia Prime Coagulation System, a cutting edge in-vitro diagnostic intended to monitor the INR of patients undergoing anticoagulation therapy. Allucent’s experts were instrumental in navigating the interactive review process with FDA and we are eager to continue our relationship into the future.” NICK BLIESNER, HEAD OF OPERATIONS UNIVERSAL BIOSENSORS “Our team successfully collaborated with Allucent’s Regulatory group on the registration of YCANTH™ (cantharidin) topical solution. The Allucent project team worked tirelessly on this registration, and genuinely shared our desire to bring this important treatment to the patients who urgently needed it. They applied their extensive expertise and experience to help us achieve our goal of a successful NDA registration in July 2023, and introduce the first and only FDA-approved treatment for molluscum contagiosum in pediatric and adult patients. We have had a positive experience working with Allucent, and I would highly recommend them for similar work.” TED WHITE, PRESIDENT AND CEO VERRICA PHARMACEUTICALS INC. HOW ALLUCENT CAN HELP Addressing Your Challenges NOT ENOUGH INTERNAL REGULATORY EXPERTISE? With 12 former global regulators, including those from the FDA, EMA, and other authorities, our team boasts in-depth knowledge of all regulatory requirements and processes allowing us to optimize your regulatory pathway to maximize the chances for first-time approval. LEARN MORE CHALLENGED WITH ALIGNING REGULATORY REQUIREMENTS AND CLINICAL PROGRAMS? Our experts create optimized drug development plans, saving you time and money. LEARN MORE ENGAGED IN FAST-PACED DEVELOPMENT, STRIVING TO MEET MILESTONES? We’re big enough to offer comprehensive services, yet small enough to provide personalized attention, and nimble enough to quickly adapt plans when needed. LEARN MORE Meet Some of Our Experts We are here to collaborate with you and be your trusted partner in navigating the regulatory complexities of drug development. Leslie DeVos President, Regulatory & Drug Development Consulting 38+ years of healthcare and industry experience with 17 years leading global regulatory and compliance business units Comprehensive knowledge of global regulatory strategies and marketing authorization submissions Extensive experience and focus in biotech and novel product development Sugato De Vice President, Regulatory Strategy, Head of MedTech Previous Branch Chief and Senior Policy Advisor with FDA’s Center for Devices and Radiological Health Expertise in regulatory and clinical strategy with deep experience in combination products, medical devices, digital health, and companion diagnostics Marcus Delatte, PhD Vice President, Regulatory Strategy 12 years at FDA as Senior Toxicology/Pharmacology Reviewer Proven expertise in translating nonclinical data to inform clinical program design Expert in developing regulatory pathways, including IND and NDA applications, and expedited programs Merribeth Adams  Sr. Vice President, Regulatory and Drug Development 40+ years of experience in clinical research and regulatory/governmental affairs Highly skilled in regulatory strategy and drug/product development on a global scale Deep knowledge of medical device, pharmaceutical, and biologics development Decades of interactions have established our reputation with regulatory agencies and strengthened our knowledge of the most efficient ways to help you reach successful outcomes. Our A-Team experts round out our clinical support with services that position your therapy for IND, IMP, or equivalent status, and product development guidance for marketing approval and beyond. Our regulatory and product development experience runs deep in the pharmaceutical, medical device, and biotechnology industries, ensuring we are an asset to your team with any kind of therapeutic innovation. EXPERIENCE THE TRANSFORMATIVE POWER OF OUR EXPERTISE Partner with Allucent to unlock the future of drug development and propel your success. CONTACT US TODAY Related Topics PRECLINICAL AND CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC)​ CLINICAL STRATEGY BIOSTATISTICAL CONSULTING REGULATORY SUBMISSIONS GXP CONSULTING FAQs 1 What makes a regulatory strategy critical for drug development success? + A regulatory strategy can help to reduce delays and improve the chances of getting approval. Developing a regulatory strategy can help ensure that your decisions are based on current requirements, that you have made an appropriate plan for submissions, and that you will have a realistic way to proceed from pre-approval through submissions and post-approval. 2 How does Allucent tailor regulatory approaches for different product types? + 3 What role does global regulatory experience play in Allucent’s strategy support? + 4 Can Allucent assist with regulatory challenges during clinical trial design? +